Apparatus and method for endoscopic colectomy

ABSTRACT

Apparatus and methods for endoscopic colectomy are described herein. A colectomy device having a first and a second tissue approximation device is mounted on a colonoscope separated from one another. During deployment of the colectomy device, a diseased portion of the colon is positioned inbetween the tissue approximation devices. The tissue approximation devices are radially expanded such that they contact and grasp the colon wall at two sites adjacent to the diseased portion of the colon. The diseased portion is separated from the omentum and is transected using a laparoscope or is drawn into the colonoscope for later removal. The tissue approximation devices are then urged towards one another over the colonoscope to approximate the two free edges of the colon into contact together where they are fastened to one another using the tissue approximation device as a surgical stapler to create an end-to-end anastomosis.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. patentapplication Ser. No. 14/199,220 (filed Mar. 6, 2014), which is acontinuation application of U.S. patent application Ser. No. 13/729,602(filed Dec. 28, 2012; now U.S. Pat. No. 8,696,694), which is adivisional application of U.S. patent application Ser. No. 12/027,739(filed Feb. 7, 2008; now U.S. Pat. No. 8,361,090 B2), which is adivisional application of U.S. patent application Ser. No. 10/327,370(filed Dec. 20, 2002; now U.S. Pat. No. 7,338,505 B2), which claims thebenefit of priority of U.S. Provisional Patent Application No.60/347,674 (filed Jan. 9, 2002), which are all incorporated herein byreference in their entirety.

FIELD OF THE INVENTION

The present invention relates generally to surgical methods andapparatus. More particularly, it relates to methods and apparatus forperforming endoscopic colectomy.

BACKGROUND OF THE INVENTION

Endoscopy studies the intraluminal aspects of hollow organs of the upperand lower intestine including the esophagus, stomach and the colonthrough cannulation of the lumen via the mouth or anus. Endoscopicpolypectomy is presently limited to a submucosal resection. Theendoscopist is often unable to completely resect a sessile polyp orlesion and therefore the patient is subjected to subsequent definitivesurgery, i.e. resection of the base of the tumor. Endoscopic polypectomycan be used to debulk sessile masses but it is unable to resect muraldisease. Incomplete resection of a sessile polyp may destroy the biopsyspecimen and alter the relationship of the gross specimen given to thepathologist thereby resulting in the pathologist possibly providingincorrect or incomplete study results. The endoscopist is also unable tocorrect uncommon, but life threatening, procedural complications such asperforations. Other cases where resection is required are invasivetumors, perforation from different causes, inflammatory bowel disease,diverticulosis and others.

Surgical approaches for resecting diseased tissue are largely practicedby making large laparotomy incisions or using minimally invasivetechniques such as laparoscopic surgery in which tissues are resectedand repaired through small incisions.

There are numerous surgical devices enabling surgeons to resect diseasedtissue and subsequently anastomose remaining tissue either through aconventional incision or using a laparoscope and making one or morerelatively small incisions. Additionally, endoscopically assistedstapling devices are known which enable surgeons to remotely anastomoselumenal structures such as the bowel. Endoscopically assisted bowelanastomosis nevertheless typically requires extralumenal assistance viaa traditional laparotomy incision or use of a laparoscope.

Trends in surgery are towards minimally invasive procedures as evidencedby developments including laparoscopic cholecystectomy, laparoscopicappendectomy and laparoscopically assisted partial colectomies andhernia repairs. All of these minimally invasive procedures involveintroducing a laparoscope through the abdominal wall and creating otherassociated openings to gain access to the peritoneal cavity in order toperform the necessary surgical procedure. Typically, general anesthesiais required. Endoscopically possible procedures include polypectomy,mucosectomy, and cauterization. During “laparoscopic colectomy” todaythe colon is separated from its omentum laparoscopically and then thecolon is exteriorized out of the abdominal cavity, through a laparotomyincision where the resection and anastomosis are performedextracorporeally.

Disadvantages of the laparoscopic method include the need to traversethe abdominal wall, increased operating time secondary to the lack ofexposure for the procedure and possibly the need to convert to an “open”laparotomy in the course of performing the procedure.

Present stapling techniques in surgery are for the most partfunctionally adequate but limited. Devices exist including the GIA andEEA staplers which can be used to transect tissue in a linear orcircular fashion, respectively, with subsequent anastomosis withstaples. The linear GIA is relatively versatile. The EEA is primarilysuited for lower colonic circular anastomosis after a lesion has beensurgically removed (via laparotomy or laparoscopically) or during acolostomy takedown procedure.

The rigid post of the EEA stapler severely limits its use, as well asrequiring that an open procedure be utilized. The steerable endoscopicstapler is useful in allowing for more bowel accessibility; however, itremains dependent upon transabdominal surgical exposure prior toutilization. While laparoscopic surgical instruments have been used forbowel anastomosis, in such procedures the bowel is exteriorized throughthe laparoscopic incision and anastomosed extracorporeally or in anaugmented stapled side-to-side fashion.

U.S. Pat. Nos. 5,868,760 and 6,264,086 describe a method and apparatusfor performing endolumenal resection of tissue, in particular forremoval of diseased portions of a patient's colon. This purelyendolumenal approach to colostomy does not fully address the surgicalanatomy of the colon. As is well known, the colon and other viscera areconnected and supported within the abdomen by the omentum, a membranousextension of the peritoneum that carries the blood supply to the colon.Resection of more than a small portion of the colon requiresmobilization of the colon from the omentum and ligation or cauterizationof the blood vessels supplying that portion of the colon. This aspect isnot addressed by the endolumenal approach described; therefore it wouldbe suitable for resecting only small portions of the colon.

Commonly owned and copending U.S. patent application Ser. Nos.09/790,204 filed Feb. 20, 2001 (now U.S. Pat. No. 6,468,203); Ser. No.09/969,927 filed Oct. 2, 2001; and Ser. No. 10/229,577 filed Aug. 27,2002, describe steerable colonoscopes that uses serpentine motion tofacilitate rapid and safe insertion of the colonoscope into a patient'scolon. The technology described therein can also be used in conjunctionwith the methods and apparatus of the present invention to facilitateendoscopic colectomy or resection of any other part of thegastrointestinal system including, but not limited to, the esophagus,duodenum, jejunum and ileum or any other tubular organ like thebronchus. These patents and patent applications, and all other patentsand patent applications referred to herein, are hereby incorporated byreference in their entirety.

SUMMARY OF THE INVENTION

In keeping with the foregoing discussion, the present invention takesthe form of methods and apparatus for performing endoscopic colectomythat combine the advantages of the laparoscopic and endolumenalapproaches. The diseased portion of the colon to be resected isidentified using either laparoscopic and/or colonoscopic techniques orusing another imaging modality. A colectomy device mounted on acolonoscope grasps the colon wall at two sites adjacent to a diseasedportion of the colon. Using laparoscopic techniques, the diseasedportion of the colon is separated from the omentum and the blood vesselssupplying it are ligated or cauterized. The colon wall is transected toremove the diseased portion and the excised tissue is removed using thelaparoscope or drawn into the colectomy device for later removal uponwithdrawal of the colonoscope. The colectomy device approximates the twoends of the colon and performs an end-to-end anastomosis. If the part tobe resected is a tumor, prior to the resection, the edges of the segmentto be resected will be stapled to sad it and prevent spillage ofmalignant cells to the healthy tissue.

The methods and apparatus of the present invention provide a number ofbenefits not realized by the prior art approaches to colectomy. Asstated above, the purely endolumenal approach does not provide forseparation of the colon from the omentum, which is necessary whenresecting more than just a small portion of the colon wall. By combininglaparoscopic techniques with a colonoscope-mounted colectomy device, thepresent invention overcomes this deficiency in the prior art allowing amore comprehensive approach to colectomy. Unlike prior art laparoscopictechniques, however, the colon does not need to be exteriorized forexcision of the diseased portion or anastomosis of the remaining colon.The colonoscope-mounted colectomy device approximates the ends of thecolon and performs an anastomosis from the interior of the lumen of thecolon. The excised tissue can be drawn into the colectomy device forremoval through the lumen of the colon along with the colonoscope or canbe taken out by the laparoscope, which can be done through a very smallincision in the patient's skin. The prior art approach also does notprotect from leaking of malignant cells to the periphery. This idea willenable sealing of the tissue with staples at its ends to prevent suchleakage. Optionally, it will be done with the help of a laparoscopicdevice that will serve as an anvil. Unlike the prior art procedure, thepresent invention will optionally use a balloon inflated in the lumen ofthe colon or any other resected organ before stapling, and by thisassure the anastomosis will be ideal with the best possibleapproximation of the edges.

The use of colonoscopic techniques in the present invention providesanother benefit not realized by a purely laparoscopic approach. Sincecolonoscopic examination is at present the most definitive diagnosticmethod for identifying diseases of the colon, locating the lesionsthrough the exterior of the colon by laparoscopy or even by directvisualization can be somewhat problematic. Using the colonoscope toidentify and isolate the diseased portion of the colon from within thelumen helps assure that the correct portions of the colon wall areexcised and makes clean surgical margins without residual disease moreassured as well.

In a preferred embodiment, the present invention utilizes a steerablecolonoscope as described in U.S. patent application Ser. No. 09/790,204(now U.S. Pat. No. 6,468,203); Ser. Nos. 09/969,927; and 10/229,577,which have been incorporated by reference. The steerable colonoscopedescribed therein provides a number of additional benefits forperforming endoscopic colectomy according to the present invention. Thesteerable colonoscope uses serpentine motion to facilitate rapid andsafe insertion of the colonoscope into the patient's colon, which allowsthe endoscopic colectomy method to be performed more quickly and moresafely. Beyond this however, the steerable colonoscope has thecapability to create a three-dimensional mathematical model or map ofthe patient's colon and the location of any lesions identified duringthe initial examination. Lesions found during a previous examination byCT, MRI or any other imaging technology can also be mapped onto thethree-dimensional mathematical model of the colon. By generating athree-dimensional map of the colon, the system knows where each part ofthe endoscope is in the colon and will be able to localize the two partsof the dissecting and stapling system exactly in the desired location.During surgery, this information can be used to quickly and accuratelyreturn the colonoscope to the location of the identified lesions wherethe colonoscope-mounted colectomy device will be used to complete theendoscopic colectomy procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a phantom drawing illustrating a diseased portion of the colonbeing separated from the omentum using laparoscopic techniques through asmall incision in a patient's abdomen.

FIG. 2 is a cutaway drawing illustrating a steerable colonoscope with acolectomy device mounted thereon being inserted through the lumen of apatient's colon.

FIG. 3 is a cutaway drawing showing the gripping mechanism of thecolonoscope-mounted colectomy device expanded within the lumen of thecolon.

FIG. 4 illustrates the colon after the diseased portion has been excisedand removed with the colonoscope-mounted colectomy device in position toapproximate the transected ends of the colon.

FIG. 5 illustrates the colonoscope-mounted colectomy device performingan end-to-end anastomosis to complete the endoscopic colectomyprocedure.

FIG. 6 shows a first embodiment of the steerable endoscope of thepresent invention.

FIG. 7 shows a second embodiment of the steerable endoscope of thepresent invention.

FIG. 8 shows a wire frame model of a section of the body of theendoscope in a neutral or straight position.

FIG. 9 shows the wire frame model of the endoscope body shown in FIG. 8passing through a curve in a patient's colon.

FIG. 10 shows a representative portion of an alternative endoscopic bodyembodiment having multiple segments interconnected by joints.

FIG. 11 shows a partial schematic representation of the embodiment ofFIG. 10 showing two segments being pivotable about two independent axes.

FIG. 12 shows a preferable endoscope embodiment having motorizedsegmented joints.

FIGS. 13A-13B show exploded isometric assembly views of two adjacentsegments and an individual segment, respectively, from the embodimentshown in FIG. 12.

FIG. 14 shows a variation of the tendon driven endoscope of the presentinvention.

FIG. 15A shows the range of motion of a controllable segment of thepresent invention actuated by three tendons.

FIGS. 15B to 15F show the use of three tendons to actuate a controllablesegment used in the endoscope of the present invention.

FIGS. 16A and 16B show the use of two tendons to actuate a controllablesegment in the endoscope of the present invention.

FIGS. 16C and 16D show the use of four tendons to actuate a controllablesegment in the endoscope of the present invention.

FIG. 17 shows a partial schematic representation of a single tendonbending a segment.

FIGS. 18A and 18B show an end view and a side view, respectively, of avertebra-type control ring which may be used to form the controllablesegments of the endoscope of the present invention.

FIG. 18C shows a side view of interconnected vertebra-type control ringsused to form the controllable segments of the endoscope of the presentinvention.

FIGS. 18D and 18E show a side view and a perspective view, respectively,of another embodiment of a vertebra-type control ring.

FIG. 19A shows a perspective view of an endoscope device variation withthe outer layers removed to reveal the control rings and backbone.

FIG. 19B shows an end view of a variation of the control ring for anendoscope of the present invention.

FIGS. 20A to 20C illustrate advancing the tendon driven endoscope of thepresent invention through a tortuous path.

FIG. 21 shows a variation of the tendon driven endoscope of the presentinvention that has segments of differing diameters.

FIG. 22 shows a variation of the tendon-driven endoscope of the presentinvention that has segments of different length.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 2 is a cutaway drawing illustrating a steerable colonoscope 100with a colectomy device 102 mounted thereon being inserted through thelumen of a patient's colon. As mentioned before, the same technique mayapply for every other tubular shaped organ. Preferably, the steerablecolonoscope 100 is constructed as described in U.S. patent applicationSer. No. 09/790,204 (now U.S. Pat. No. 6,468,203); Ser. No. 09/969,927(now U.S. Pat. No. 6,610,007); and Ser. No. 10/229,577 (now U.S. Pat.No. 6,858,005), with multiple articulating segments that are controlledto move with a serpentine motion that facilitates insertion andwithdrawal of the colonoscope with a minimum of contact and stressapplied to the colon walls. Additional details and various embodimentsof the steerable colonscope 100 are described below with reference toFIGS. 6-22. In addition, the control system of the steerable colonoscope100 has the capability to construct a three-dimensional mathematicalmodel or map of the colon as it advances through lumen under control ofthe operator. The three-dimensional mathematical model of the colon andthe location and nature of any lesions identified in the course of aninitial colonoscopic examination can be stored and used in performanceof the endoscopic colectomy procedure. In alternate embodiments, thecolectomy device 102 of the present invention may be mounted on acolonoscope of a different design and construction.

The colectomy device 102 can be permanently or removably mounted on thesteerable colonoscope 100. The colectomy device 102 has a distalcomponent 104 and a proximal component 106. The distal component 104 andthe proximal component 106 each have an expandable member 108 and agripping mechanism 110 for gripping the wall of the colon. Theexpandable member 108 may be an inflatable balloon or a mechanicallyexpandable mechanism. The gripping mechanism 110 may comprise aplurality of circumferentially located ports within which attachmentpoints 112, e.g., needles, hooks, barbs, etc., may be retractablypositioned about an exterior surface of the expandable member 108.Alternatively, the gripping mechanism 110 may utilize a vacuum gripperthrough a plurality of circumferentially located ports around the distalcomponent 104 and/or the proximal component 106 or other known grippingmechanisms In the case of the vacuum gripper, gripping mechanism 110 isin fluid communication through the ports and through the colonoscope 100to the proximal end of the colonoscope 100 to a vacuum pump (not shown).At least one, and optionally both, of the distal component 104 and theproximal component 106 are movable longitudinally with respect to thebody of the steerable colonoscope 100. Rails, grooves or the like 114may be provided on the body of the steerable colonoscope 100 for guidingthe longitudinal movement of the distal component 104 and the proximalcomponent 106.

In addition, the colectomy device 102 includes a surgical stapler 116 orother anastomosis mechanism. The surgical stapler 116 is carried oneither the distal component 104 or the proximal component 106 and astapler anvil 118 is carried on the other of these components. Thesurgical stapler 116 may be configured similarly to any number ofconventional stapling devices which are adapted to actuate staples intotissue. Another option is that there is a stapler and an anvil on bothcomponents for stapling and sealing the edges. Optionally, the colectomydevice 102 may include a cutting device and/or electrocautery and/or alaser device for transecting the colon wall. Optionally, the colectomydevice 102 may also include a vacuum mechanism or the like for drawingthe excised tissue into the colectomy device 102 for later removal alongwith the steerable colonoscope 100.

FIG. 2 shows the steerable colonoscope 100 with the expandable members108 of the distal component 104 and the proximal component 106 in acontracted or deflated condition for easy passage through the lumen ofthe patient's colon. The control system of the steerable colonoscope 100monitors the position of each segment of the colonoscope 100 as it isadvanced within the colon and can signal to the operator when thesegments carrying the distal component 104 and the proximal component106 of the colectomy device 102 are correctly positioned with respect toa previously detected lesion in the colon. Alternatively, the controlsystem of the steerable colonoscope 100 can be programmed to advance thecolonoscope 100 automatically through the lumen of the colon and to stopit when the distal component 104 and the proximal component 106 of thecolectomy device 102 are correctly positioned with respect to the lesionin the colon. Alternatively, the control system will be able toautomatically guide and deliver the two components to the desiredlocation after the colonoscope has been inserted to the colon.

FIG. 3 is a cutaway drawing showing the expandable members 108 of thedistal component 104 and the proximal component 106 of thecolonoscope-mounted colectomy device 102 expanded within the lumen ofthe colon so that the gripping mechanism 110 grips the wall of thecolon. The distal component 104 and the proximal component 106 may beexpanded through any number of expansion devices. For instance, they maybe radially expanded upon spoke-like support structures or they may beconfigured to radially expand in a rotational motion until the desiredexpansion diameter is attained. At this point, with the diseased portionof the colon identified and isolated by the colonoscope-mountedcolectomy device 102, the diseased portion is separated from the omentumand the blood vessels supplying it are ligated and/or cauterized usinglaparoscopic techniques. FIG. 1 is a phantom drawing illustrating adiseased portion of the colon being separated from the omentum usinglaparoscopic techniques through a small incision in a patient's abdomen.

Next, the diseased portion of the colon is excised by transecting thecolon at the proximal and distal end of the diseased portion. The colonmay be transected using laparoscopic techniques or using a cuttingmechanism and/or electrocautery device mounted on the colectomy device102. The excised tissue is removed using the laparoscope or drawn intothe colectomy device 102 for later removal upon withdrawal of thesteerable colonoscope 100. FIG. 4 illustrates the colon after thediseased portion has been excised and removed with thecolonoscope-mounted colectomy device 102 in position to approximate thetransected ends of the colon.

The remaining ends of the colon are approximated one to the other bymoving the distal component 104 and/or the proximal component 106longitudinally with respect to the body of the steerable colonoscope100, as shown by the arrows. Optionally, the proximal component 106 maybe longitudinally translated towards the distal component 104 or bothcomponents 104, 106 may be approximated simultaneously towards oneanother. The ends of the colon are stapled to one another to create anend-to-end anastomosis 120 using the surgical stapler 116 and stapleranvil 118 on the colectomy device 102. Once the ends of the tissue havebeen approximated, staples or other fastening devices, e.g., clips,screws, adhesives, sutures, and combinations thereof, etc., may beactuated through the surgical stapler 116 such that they pierce bothends of the tissue against the stapler anvil 118. FIG. 5 illustrates thecolonoscope-mounted colectomy device performing an end-to-endanastomosis 120 to complete the endoscopic colectomy procedure. Once theanastomosis 120 is complete, the expandable members 108 of the distalcomponent 104 and the proximal component 106 are deflated or contractedand the steerable colonoscope 100 and the colectomy device 102 arewithdrawn from the patient's body. The expanded members will assure avery accurate end-to-end anastomosis and prevent stenosis that canhappen as a result of inaccurate approximation of the two ends.

In an alternative method using the colonoscope-mounted colectomy device102, the diseased portion of the colon may be excised using a cuttingdevice within the colectomy device 102 after the ends of the diseasedportion have been approximated and anastomosed. The excised tissue isdrawn into the colectomy device 102 and removed when the steerablecolonoscope 100 is withdrawn from the patient.

In another alternative method, the colectomy procedure may be performedentirely from the endolumenal approach using the colonoscope-mountedcolectomy device 102 without laparoscopic assistance. This method wouldbe particularly advantageous for resection of small portions of thecolon where it may not be necessary to mobilize an extended portion ofthe colon from the omentum to achieve successful approximation andanastomosis. The three-dimensional mapping capability of the steerablecolonoscope 102 would be used to locate previously identified lesionswithout laparoscopic assistance.

Steerable Colonoscope

FIG. 6 shows a first embodiment of the steerable endoscope 100 of thepresent invention. The endoscope 100 has an elongate body 103 with amanually or selectively steerable distal portion 105 and anautomatically controlled proximal portion 107. The selectively steerabledistal portion 105 can be selectively steered or bent up to a full 180degree bend in any direction. A fiberoptic imaging bundle 113 and one ormore illumination fibers 115 extend through the body 103 from theproximal end 111 to the distal end 109. Alternatively, the endoscope 100can be configured as a video endoscope with a miniaturized video camera,such as a CCD camera, positioned at the distal end 109 of the endoscopebody 103. The images from the video camera can be transmitted to a videomonitor by a transmission cable or by wireless transmission. Optionally,the body 103 of the endoscope 100 may include one or two instrumentchannels 117, 119 that may also be used for insufflation or irrigation.The body 103 of the endoscope 100 is highly flexible so that it is ableto bend around small diameter curves without buckling or kinking. Whenconfigured for use as a colonoscope, the body 103 of the endoscope 100is typically from 135 to 185 cm in length and approximately 12-13 mm indiameter. The endoscope 100 can be made in a variety of other sizes andconfigurations for other medical and industrial applications.

A proximal handle 121 is attached to the proximal end 111 of theelongate body 103. The handle 121 includes an ocular 124 connected tothe fiberoptic imaging bundle 113 for direct viewing and/or forconnection to a video camera 126. The handle 121 is connected to anillumination source 128 by an Rumination cable 134 that is connected toor continuous with the illumination fibers 115. A first luer lockfitting 130 and a second luer lock fitting 132 on the handle 121 areconnected to the instrument channels 117, 119.

The handle 121 is connected to an electronic motion controller 140 byway of a controller cable 136. A steering control 122 is connected tothe electronic motion controller 140 by way of a second cable 138. Thesteering control 122 allows the user to selectively steer or bend theselectively steerable distal portion 105 of the body 103 in the desireddirection. The steering control 122 may be a joystick controller asshown, or other known steering control mechanism. The electronic motioncontroller 140 controls the motion of the automatically controlledproximal portion 107 of the body 103. The electronic motion controller140 may be implemented using a motion control program running on amicrocomputer or using an application-specific motion controller.Alternatively, the electronic motion controller 140 may be implementedusing a neural network controller.

An axial motion transducer 150 is provided to measure the axial motionof the endoscope body 103 as it is advanced and withdrawn. The axialmotion transducer 150 can be made in many possible configurations. Byway of example, the axial motion transducer 150 in FIG. 6 is configuredas a ring 152 that surrounds the body 103 of the endoscope 100. Theaxial motion transducer 150 is attached to a fixed point of reference,such as the surgical table or the insertion point for the endoscope 100on the patient's body. As the body 103 of the endoscope 100 slidesthrough the axial motion transducer 150, it produces a signal indicativeof the axial position of the endoscope body 103 with respect to thefixed point of reference and sends a signal to the electronic motioncontroller 140 by telemetry or by a cable (not shown). The axial motiontransducer 150 may use optical, electronic or mechanical means tomeasure the axial position of the endoscope body 103. Other possibleconfigurations for the axial motion transducer 150 are described below.

FIG. 7 shows a second embodiment of the endoscope 100 of the presentinvention. As in the embodiment of FIG. 6, the endoscope 100 has anelongate body 103 with a selectively steerable distal portion 105 and anautomatically controlled proximal portion 107. The steering control 122is integrated into proximal handle 121 in the form or one or two dialsfor selectively steering the selectively steerable distal portion 105 ofthe endoscope 100. Optionally, the electronic motion controller 140 maybe miniaturized and integrated into proximal handle 121, as well. Inthis embodiment, the axial motion transducer 150 is configured with abase 154 that is attachable to a fixed point of reference, such as thesurgical table. A first roller 156 and a second roller 158 contact theexterior of the endoscope body 103. A multi-turn potentiometer 160 orother motion transducer is connected to the first roller 156 to measurethe axial motion of the endoscope body 103 and to produce a signalindicative of the axial position.

The endoscope 100 may be manually advanced or withdrawn by the user bygrasping the body 103 distal to the axial motion transducer 150.Alternatively, the first roller 156 and/or second roller 158 may beconnected to a motor 162 for automatically advancing and withdrawing thebody 103 of the endoscope 100.

FIG. 8 shows a wire frame model of a section of the body 103 of theendoscope 100 in a neutral or straight position. Most of the internalstructure of the endoscope body 103 has been eliminated in this drawingfor the sake of clarity. The endoscope body 103 is divided up intosections 1, 2, 3 . . . 10, etc. The geometry of each section is definedby four length measurements along the a, b, c and d axes. For example,the geometry of section 1 is defined by the four length measurementsl_(1a), I_(1b), l_(1c), l_(1d), and the geometry of section 2 is definedby the four length measurements l_(2a), l_(2b), l_(2c), 1 _(2d), etc.Preferably, each of the length measurements is individually controlledby a linear actuator (not shown). The linear actuators may utilize oneof several different operating principles. For example, each of thelinear actuators may be a self-heating NiTi alloy linear actuator or anelectrorheological plastic actuator, or other known mechanical,pneumatic, hydraulic or electromechanical actuator. The geometry of eachsection may be altered using the linear actuators to change the fourlength measurements along the a, b, c and d axes. Preferably, the lengthmeasurements are changed in complementary pairs to selectively bend theendoscope body 103 in a desired direction. For example, to bend theendoscope body 103 in the direction of the a axis, the measurementsl_(1a), l_(2a), l_(3a) . . . l_(10a), would be shortened and themeasurements l_(1b), l_(2b), l_(2c) . . . l_(10b), would be lengthenedan equal amount. The amount by which these measurements are changeddetermines the radius of the resultant curve.

In the selectively steerable distal portion 105 of the endoscope body103, the linear actuators that control the a, b, c and d axismeasurements of each section are selectively controlled by the userthrough the steering control 122. Thus, by appropriate control of the a,b, c and d axis measurements, the selectively steerable distal portion105 of the endoscope body 103 can be selectively steered or bent up to afull 180° in any direction.

In the automatically controlled proximal portion 107, however, the a, b,c and d axis measurements of each section are automatically controlledby the electronic motion controller 140, which uses a curve propagationmethod to control the shape of the endoscope body 103. To explain howthe curve propagation method operates, FIG. 9 shows the wire frame modelof a part of the automatically controlled proximal portion 107 of theendoscope body 103 shown in FIG. 8 passing through a curve in apatient's colon C. For simplicity, an example of a two-dimensional curveis shown and only the a and b axes will be considered. In athree-dimensional curve all four of the a, b, c and d axes would bebrought into play.

In FIG. 9, the endoscope body 103 has been maneuvered through the curvein the colon C with the benefit of the selectively steerable distalportion 105 (this part of the procedure is explained in more detailbelow) and now the automatically controlled proximal portion 107 residesin the curve. Sections 1 and 2 are in a relatively straight part of thecolon C, therefore l_(1a),=l_(1b), and l_(2a),=l_(2b),. However, becausesections 3-7 are in the S-shaped curved section, l_(3a),<1 _(3b),l_(4a),<l_(4b), and l_(5a),<l_(5b), but l_(6a)>l_(6b), l_(7a)>l_(7ab)and l_(8a)>l_(8ab). When the endoscope body 103 is advanced distally byone unit, section 1 moves into the position marked 1′, section 2 movesinto the position previously occupied by section 1, section 3 moves intothe position previously occupied by section 2, etc. The axial motiontransducer 150 produces a signal indicative of the axial position of theendoscope body 103 with respect to a fixed point of reference and sendsthe signal to the electronic motion controller 140. Under control of theelectronic motion controller 140, each time the endoscope body 103advances one unit, each section in the automatically controlled proximalportion 106 is signaled to assume the shape of the section thatpreviously occupied the space that it is now in. Therefore, when theendoscope body 103 is advanced to the position marked 1′,l_(1a)=l_(1ab), l_(2a)=l_(2b), l_(3a)=l_(3b), l_(4a)<l_(4b),l_(5a)<l_(5b), l_(6a)<l_(6b), l_(7a)>l_(7b), l_(8a)>l_(8b), andl_(9a)>l_(9b), and, when the endoscope body 103 is advanced to theposition marked 1″, l_(1a)=l_(1b), l_(2a)=l_(2b), l_(3a)=l_(3b),l_(4a)=l_(4b), l_(5a)<l_(5b), l_(6a)<l_(6b), l_(7a)<l_(7b),l_(8a)>l_(8b), l_(9a)>l_(9b), and l_(10a)>l_(10b). Thus, the S-shapedcurve propagates proximally along the length of the automaticallycontrolled proximal portion 107 of the endoscope body 103. The S-shapedcurve appears to be fixed in space, as the endoscope body 103 advancesdistally.

Similarly, when the endoscope body 103 is withdrawn proximally, eachtime the endoscope body 103 is moved proximally by one unit, eachsection in the automatically controlled proximal portion 107 is signaledto assume the shape of the section that previously occupied the spacethat it is now in. The S-shaped curve propagates distally along thelength of the automatically controlled proximal portion 107 of theendoscope body 103, and the, S-shaped curve appears to be fixed inspace, as the endoscope body 103 withdraws proximally.

Whenever the endoscope body 103 is advanced or withdrawn, the axialmotion transducer 150 detects the change in position and the electronicmotion controller 140 propagates the selected curves proximally ordistally along the automatically controlled proximal portion 107 of theendoscope body 103 to maintain the curves in a spatially fixed position.This allows the endoscope body 103 to move through tortuous curveswithout putting unnecessary force on the wall of the colon C.

FIG. 10 shows a representative portion of an alternative endoscopic bodyembodiment 190 which has multiple segments 192 interconnected by joints194. In this embodiment, adjacent segments 192 can be moved or angledrelative to one another by a joint 194 having at least onedegree-of-freedom, and preferably having multiple degrees-of-freedom,preferably about two axes as shown here. As seen further in FIG. 4, apartial schematic representation 196 of the embodiment 190 is shownwhere two segments 192 may be rotated about joint 194 about the twoindependent axes. The range of motion may be described in relation tospherical axes 198 by angles α and β

As mentioned above, such a segmented body may be actuated by a varietyof methods. A preferable method involves the use of electromechanicalmotors individually mounted on each individual segment to move thesegments relative to one another. FIG. 12 shows a preferable embodiment200 having motorized segmented joints. Each segment 192 is preferablycomprised of a backbone segment 202, which also preferably defines atleast one lumen running through it to provide an access channel throughwhich wires, optical fibers, air and/or water channels, variousendoscopic tools, or any variety of devices and wires may be routedthrough. The backbone segment may be made of a variety of materialswhich are preferably biocompatible and which provide sufficient strengthto support the various tools and other components, e.g., stainlesssteel. Although much of the description is to an individual segment 192,each of the segments 192 are preferably identical, except for thesegment (or first few segments) located at the distal tip, and thefollowing description readily applies to at least a majority of thesegments 192.

A single motor, or multiple motors depending upon the desired result andapplication, may be attached to at least a majority of the segments. Anembodiment having a single motor on a segment is illustrated in FIG. 12where an individual motor 204 is preferably attached to backbone 202 andis sufficiently small and compact enough so as to present a relativelysmall diameter which is comfortable and small enough for insertion intoa patient without trauma. Motor 204, which is shown here as being asmall brushed DC motor, may be used for actuating adjacent segments 192and may be controlled independently from other motors. Various motors,aside from small brushed DC motors, may also be used such as AC motors,linear motors, etc. Each motor 204 also preferably contains within thehousing not only the electromechanical motor assembly EM itself, butalso a gear reduction stage GR, and a position encoder PE. A gearreduction stage GR attached to the motor assembly EM will allow for theuse of the motor 204 in its optimal speed and torque range by changinghigh-speed, low-torque operating conditions into a more usefullow-speed, high-torque output. The position encoder PE may be aconventional encoder to allow the controlling computer to read theposition of the segment's joint 194 by keeping track of the angularrotational movement of the output shaft of the motor 204.

Each motor 204 has a rotatable shaft which extends from an end of themotor 204 to provide for the transmission of power to actuate thesegments 192. Upon this shaft, a spool 206 may be rotatingly attachedwith a first end of the cable 208 further wound about the spool 206. Thecable 208 may then be routed from spool 206 through a channel 212 whichis defined in the cable guide 210 and out through opening 214 (as seenin greater detail in FIGS. 13A-13B) to cable anchor 216, to which thesecond end of the cable 208 is preferably attached, e.g., by crimpingand/or soldering. The cable guide 210 serves to capture the cable 208that is wound about the spool 206. The cable anchor 216 is attachedacross a universal joint pivot 220 to an adjacent segment 192 via a pin218 and may be shaped like a conventional electronic ring connectorhaving a round section defining a hole therethrough for mounting to thesegment 192 and an extension protruding from the anchor 216 forattaching the second end of the cable 208. Cable 208 may comprise a widevariety of filaments, strands, wires, chains, braids, etc. any of whichmay be made of a wide variety of biocompatible materials, e.g., metalssuch as stainless steel, polymers such as plastics and Nylon, etc.

In operation, when the motor 204 is operated to spin the shaft in afirst direction, e.g., clockwise, the spool 206 rotates accordingly andthe cable 208 pulls in a corresponding direction on the adjacent segment192 and transmits the torque to subsequently actuate it along a firstaxis. When the motor 204 is operated to spin the shaft in a seconddirection opposite to the first, e.g., counter-clockwise, the spool 206again rotates accordingly and the cable 208 would then pull in thecorresponding opposing direction on the adjacent segment 192 tosubsequently transmit the torque and actuate it in the oppositedirection.

FIGS. 13A and 13B show exploded isometric assembly views of two adjacentsegments and an individual segment, respectively, from the embodimentshown in FIG. 12. As seen in FIG. 13A, backbone 202 is seen with thelumen 221, which may be used to provide a working channel, as describedabove. Also seen are channel 212 defined in cable guide 210 as well asopening 214 for the cable 208 to run through. In interconnectingadjacent segments and to provide the requisite degree-of-freedom betweensegments, a preferable method of joining involves using the universaljoint pivot 220. However, other embodiments, rather than using auniversal joint pivot 220, may use a variety of joining methods, e.g., aflexible tube used to join two segments at their respective centers, aseries of single degree-of-freedom joints that may be closely spaced,etc. This particular embodiment describes the use of the universal jointpivot 220. At the ends of backbone 202 adjacent to other segments, apair of universal yoke members 224 may be formed with a pair ofcorresponding pin openings 226. As the universal joint pivot 220 isconnected to a first pair of yoke members 224 on one segment, acorresponding pair of yoke members 224 from the adjacent segment mayalso be attached to the joint pivot 220.

As seen further in FIG. 13B, the universal joint pivot 220 is shown inthis embodiment as a cylindrical ring having two sets of opposingreceiving holes 228 for pivotally receiving corresponding yoke members224. The receiving holes 228 are shown as being spaced apart at90.degree. intervals, however, in other variations, receiving holes maybe spaced apart at other angles depending upon the desireddegree-of-freedom and application. Also seen is an exploded assembly ofspool 206 removed from motor 204 exposing drive shaft 205. With motor204 displaced from backbone 202, the groove 230 is revealed as formed inthe backbone 202. This groove 230 may be depressed in backbone 202 topreferably match the radius of the motor 204 housing not only to helplocate the motor 204 adjacent to backbone 202, but also to help inreducing the overall diameter of the assembled segment. The motor 204may be attached to the backbone 202 by various methods, e.g., adhesives,clamps, bands, mechanical fasteners, etc. A notched portion 232 may alsobe formed in the cable guide 210 as shown to help in further reducingsegment diameter.

Prior to insertion into a patient, the endoscope 200 may optionally beconfigured to have a diagnostic check performed automatically. When theendoscope 200 is wound onto a drum, adjacent segments 192 will have apredetermined angle relative to one another, as determined initially bythe diameter of the drum and the initial configuration of the storageunit in which the endoscope 200 may be positioned. During a diagnosticcheck before insertion, a computer may be configured to automaticallysense or measure the angles between each adjacent segments 192. If anyof the adjacent segments 192 indicate a relative measured angle out of apredetermined acceptable range of angles, this may indicate a segment192 being out of position and may indicate a potential point of problemsduring endoscope 200 use. Accordingly, the computer may subsequentlysound an audible or visual alarm and may also place each of the segments192 into a neutral position to automatically prevent further use or toprevent any trauma to the patient.

FIG. 14 shows a variation of the tendon driven endoscope 20 of thepresent invention. The endoscope 20 has an elongate body 21 with amanually or selectively steerable distal portion 24, an automaticallycontrolled portion 28, and a flexible and passively manipulated proximalportion 22, which may be optionally omitted from the device. Thesteerable distal portion 24 can be articulated by hand or withmechanical assistance from actuators The automatically controlledportion 28 is segmented, and each segment is capable of bending througha full range of steerable motion. The distal portion 24 is also acontrollable segment.

The selectively steerable distal portion 24 can be selectively steeredor bent up to, e.g., a full 180.degree. bend in any direction 26, asshown. A fiberoptic imaging bundle 40 and one or more illuminationfibers 42 may extend through the body 21 from the proximal portion 22 tothe distal portion 24. Alternatively, the endoscope 20 may be configuredas a video endoscope with a miniaturized video camera, such as a CCD orCMOS camera, positioned at the distal portion 24 of the endoscope body21. The images from the video camera can be transmitted to a videomonitor by a transmission cable or by wireless transmission where imagesmay be viewed in real-time and/or recorded by a recording device ontoanalog recording medium, e.g., magnetic tape, or digital recordingmedium, e.g., compact disc, digital tape, etc. LEDs or other lightsources could also be used for illumination at the distal tip of theendoscope.

The body 21 of the endoscope 20 may also include one or more accesslumens 38 that may optionally be used for illumination fibers forproviding a light source, insufflation or irrigation, air and waterchannels, and vacuum channels. Generally, the body 21 of the endoscope20 is highly flexible so that it is able to bend around small diametercurves without buckling or kinking while maintaining the variouschannels intact. When configured for use as a colonoscope, the body 21of the endoscope 20 may range typically from 135 to 185 cm in length andabout 13-19 mm in diameter. The endoscope 20 can be made in a variety ofother sizes and configurations for other medical and industrialapplications.

The controllable portion 28 is composed of at least one segment 30, andpreferably several segments 30, which are controllable via a computerand/or electronic controller (controller) 45 located at a distance fromthe endoscope 20. Each of the segments 30 has tendons mechanicallyconnected to actuators to allow for the controlled motion of thesegments 30 in space. The actuators driving the tendons may include avariety of different types of mechanisms capable of applying a force toa tendon, e.g., electromechanical motors, pneumatic and hydrauliccylinders, pneumatic and hydraulic motors, solenoids, shape memory alloywires, electronic rotary actuators or other devices or methods as knownin the art. If shape memory alloy wires are used, they are preferablyconfigured into several wire bundles attached at a proximal end of eachof the tendons within the controller. Segment articulation may beaccomplished by applying energy, e.g., electrical current, heat, etc.,to each of the bundles to actuate a linear motion in the wire bundleswhich in turn actuate the tendon movement. The linear translation of theactuators within the controller may be configured to move over arelatively short distance, e.g., within a few inches or less such as.+−.1 inch, to accomplish effective articulation depending upon thedesired degree of segment movement and articulation.

It is preferable that the length of the insertable portion of theendoscope comprises controllable segments 30, although a passiveproximal portion 22 can also be used. This proximal portion 22 ispreferably a flexible tubing member that may conform to an infinitevariety of shapes, and may be made from a variety of materials such asthermoset and then noplastic polymers which are used for fabricating thetubing of conventional endoscopes.

Each segment 30 preferably defines at least one lumen running throughoutto provide an access channel through which wires, optical fibers, airand/or water channels, various endoscopic tools, or any variety ofdevices and wires may be routed. A polymeric covering, or sheath, 39 mayalso extend over the body of the endoscope 21 including the controllableportion 28 and steerable distal portion 24. This sheath 39 canpreferably provide a smooth transition between the controllable segments30, the steerable distal portion 24, and the flexible tubing of proximalportion 22.

A handle 32 may be attached to the proximal end of the endoscope. Thehandle 32 may include an ocular connected to the fiberoptic imagingbundle 42 for direct viewing. The handle 32 may otherwise have aconnector 54 for connection to a video monitor, camera, e.g., a CCD orCMOS camera, or a recording device 52. The handle 32 may be connected toan illumination source 43 by an illumination cable 44 that is connectedto or continuous with the illumination fibers 42. Alternatively, some orall of these connections could be made at the controller 45. Luer lockfittings 34 may be located on the handle 32 and connected to the variousinstrument channels.

The handle 32 may be connected to a motion controller 45 by way of acontroller cable 46. A steering controller 47 may be connected to themotion controller 45 by way of a second cable 48 or it may optionally beconnected directly to the handle 32. Alternatively, the handle may havethe steering control mechanism integrated directly into the handle,e.g., in the form of a joystick, conventional disk controllers such asdials, pulleys or wheels, etc. The steering controller 47 allows theuser to selectively steer or bend the selectively steerable distalportion 24 of the body 21 in the desired direction 26. The steeringcontroller 47 may be a joystick controller as shown, or other steeringcontrol mechanism, e.g., dual dials or rotary knobs as in conventionalendoscopes, track balls, touchpads, mouse, or sensory gloves. The motioncontroller 45 controls the movement of the segmented automaticallycontrolled proximal portion 28 of the body 21. This controller 45 may beimplemented using a motion control program running on a microcomputer orusing an application-specific motion controller. Alternatively, thecontroller 45 may be implemented using, e.g., a neural networkcontroller.

The actuators applying force to the tendons may be included in themotion controller unit 45, as shown, or may be located separately andconnected by a control cable. The tendons controlling the steerabledistal portion 24 and the controllable segments 30 extend down thelength of the endoscope body 21 and connect to the actuators. FIG. 14shows a variation in which the tendons pass through the handle 32 andconnect directly to the motion controller 45 via a quick-releaseconnector 60. In this variation, the tendons are part of the controlcable 46, although they could independently connect to the actuators, solong as the actuators are in communication with the controller 45.

An axial motion transducer (also called a depth referencing device ordatum) 49 may be provided for measuring the axial motion, i.e., thedepth change, of the endoscope body 21 as it is advanced and withdrawn.The depth referencing device 49 can be made in many possibleconfigurations. For example, the axial motion transducer 49 in FIG. 14is configured as a ring 49 that may surround the body 21 of theendoscope 20. The axial motion transducer 49 is preferably attached to afixed point of reference, such as the surgical table or the insertionpoint for the endoscope 20 on the patient's body. As the body 21 of theendoscope 20 slides through the axial motion transducer 49, it indicatesthe axial position of the endoscope body 21 with respect to the fixedpoint of reference and sends a signal to the electronic controller 45 bytelemetry or by a cable. The axial motion transducer 49 may use optical,electronic, magnetic, radio frequency or mechanical methods to measurethe axial position of the endoscope body 21.

When the endoscope body 21 is advanced or withdrawn, the axial motiontransducer 49 detects the change in position and signals the motioncontroller 45. The controller can use this information to propagate theselected curves proximally or distally along the controllable portion 28of the endoscope body 21 to keep the endoscope actively following thepathway selected by the user steering the distal portion 24. The axialmotion transducer 49 also allows for the incrementing of a current depthwithin the colon C by the measured change in depth. This allows theendoscope body 21 to be guided through tortuous curves without puttingunnecessary force on the wall of the colon C.

FIG. 15A shows an example of the resulting segment articulation whichmay be possible through the use of two or three tendons to articulatethe controllable segments, including the steerable distal section. FIG.15A shows one example of a possible range of motion of a controllablesegment of the present invention actuated, in this example, by threetendons. A segment in the relaxed, upright position 301 can be bent invirtually any direction relative to the x-y plane. The figure, as anillustrative example, shows a segment 302 that has been bent down and atan angle relative to its original position 301. The angles α and βdescribe the bend assumed by the segment. Angle β gives the angle in thex-y plane, while a is the angle describing the motion in the x-z plane.In one variation, the controllable segments of the endoscope can bendthrough all 360° in the β angle and up to 90° in thea angle. An angle agreater than 90° would result in looping of the endoscope. In FIG. 15A,the segment is shown bent approximately 45° along angle a. The freedomof movement of a segment is, in part, determined by the articulationmethod, the size of the segment, the materials from which it isconstructed, and the manner in which it is constructed, among others.Some of these factors are discussed herein.

The steerable distal portion, as well as the endoscope and thecontrollable segments are bendable but preferably not compressible orexpansible. Thus, in FIG. 15A, the centerline 304 of the relaxed segment301 is approximately the same length as the centerline 306 of thesegment after bending 302.

FIGS. 15B to 15F show the use of three tendons to actuate a controllablesegment used in an endoscope of the present invention. The tendons shownin this example are all Bowden type cables 310 that have an internalcable 312 coaxially surrounded by a housing or sleeve 314 in which thecable is free to move. Bowden cables can be used to apply either tensileor compressive forces, i.e., they may be pushed or pulled, to articulatethe endoscope and can be actuated remotely to deliver forces as desiredat locations along the endoscope. Force from a tendon is exerted acrossor through the segment by attaching the tendon cable at the distal endof the segment 320 and the tendon housing 314 at the proximal end of thesegment 322. FIG. 15B shows a view of the top of the segment with threeattachment sites for the tendon cables indicated 320.

In one variation, three tendons are used to actuate each segment,including the steerable distal portion, although four or more tendonscould be used. Three tendons can reliably articulate a segment in anydirection without having to rotate the segment or endoscope about itslongitudinal axis. The three cable tendons 312 are preferably attachedat the distal end of the segment 320 close to the segment's edge, spacedequally apart. In FIG. 15B, tendons are attached at the two o'clock, sixo'clock and 10 o'clock positions. It is desirable to use fewer tendons,because of space concerns, since the tendons controlling each segmentproject proximally to the actuators. Thus, two tendons could be used tocontrol a segment. It may also be desirable to include one or morebiasing element, e.g., a spring, to assist in articulating a segment inthree dimensions. In another variation, two tendons may be used toarticulate a segment in three dimensional space by controlling motion intwo directions while rotating the segment about its longitudinal axis.

FIG. 15C shows a relaxed segment with three tendons attached. The tendonsleeves 314 are shown attached to the proximal end of the segment 322directly below the corresponding cable attachment sites. FIGS. 15D to15F show this segment bent by each of the controlling tendons 310separately.

As shown in FIG. 15D, applying tension by pulling on the first tendon330 results in a bending in the direction of the first tendon 330. Thatis, looking down on the top of the unbent segment (as in FIG. 15B), ifthe first tendon is attached at the six o'clock position, then pullingon just this tendon results in bending the segment towards the sixo'clock position. Likewise, in FIG. 15E, putting tension only on asecond tendon 332 attached at the two o'clock position results inbending the segment towards the two o'clock direction. Finally, pullingon the tendon in the ten o'clock position 334 bends the segment towardsthe ten o'clock direction. In all cases, the bending is continuous; thegreater the tension applied, the further the bending (the α angle, inthe x-z plane of FIG. 15A). A segment can be bent in any direction bypulling on individual tendons or a combination of two tendons. Thus, tobend the segment in the twelve o'clock direction, both the second 332and the third 334 tendon could be pulled with equal force.Alternatively, first tendon 330 in the six o'clock position may bepushed either alone or in combination with second 332 and third tendons334 being pulled to result in the same configuration.

FIGS. 16A and 16B show a variation in which a segment is articulated bytwo tendons and one biasing element. FIG. 16A shows a planar top view ofthe segment. The attachment sites for the biasing element 340 and thetwo tendons 320 are spaced around the perimeter of the distal end of thesegment as shown. The tendons 320 may be attached at the two o'clock andten o'clock positions, looking down on the top of the section, and thebiasing element 340 is attached at the six o'clock position. FIG. 16Bshows a perspective view of the segment in the unbent configuration. Inthis variation, the biasing element is configured to apply tension tothe side of the segment such that it will bend towards the six o′clockposition. The biasing element can be any element that can applycompressive or tensile forces across the segment, e.g. a spring, elasticelement, a piston, etc. The segment is held in the neutral or unbentposition shown in FIG. 16B by applying tension from both tendons 312.Controlling the amount of tension applied by the tendons results inbending of the segment in three dimensional space. More than one biasingelement could also be used with two or more tendons. For example, abiasing element could be located opposite each tendon.

Alternatively, if the tendon is a push-pull cable, and each tendon canapply compression as well as tension, then two tendons can control themotion of segment without any biasing element at all.

More than three tendons can also be used to control the bending of asegment. FIG. 16C shows a top planar view of a segment that iscontrolled by four tendons attached in the eleven o'clock, two o'clock,five o'clock and eight o'clock positions. As with the three-tendonembodiment, tension applied on one or a combination of the tendonsresults in shortening the side of the segment. Thus, if tension isapplied only on the tendon attached distally at the eleven o'clockposition 355, the corresponding side of the tendon will shorten, and thesegment will bend in the eleven o'clock direction.

In all these variations, the circumferential locations of the tendonsand/or biasing elements are illustrative and are not intended to belimited to the examples described herein. Rather, they may be variedaccording to the desired effects as understood by one of skill in theart.

FIG. 17 shows a partial schematic representation of a single tendonbending a segment. For clarity, the other parts of a complete endoscope,including other tendons and segments, have been omitted from FIG. 17.Tension applied to a tendon cable is transferred across the entiresegment, resulting in bending. By using a Bowden cable 310 whose sleeve314 is attached to the base 322 of the segment and also fixed at theproximal actuator end 403, only the intended segment 401 is bent byapplying tension to the tendon 312, and more proximal segments areunaffected. The tendon is placed in tension by the actuator 410, whichis shown, in this variation, as a motor pulling on the tendon cable 312.

Linked control rings may provide the flexible structure needed toconstruct the steerable distal portion and the controllable segments.Two examples of the types of control rings that may be utilized areshown. The first is shown in FIG. 18A which shows a vertebra-typecontrol ring that forms the controllable segments of the presentinvention. FIG. 18A shows an end view of a single vertebra. Eachring-shaped vertebra 501 can define a central channel or aperture 504 orapertures that can collectively form the internal lumen of the device aspreviously described. The vertebrae may have two pairs of hinges; thefirst pair 506 projecting perpendicularly from a first face of thevertebra and a second pair 508, located 90° around the circumferencefrom the first pair, projecting perpendicularly away from the face ofthe vertebra on a second face of the vertebra opposite to the firstface. The hinges shown in FIGS. 18A and 18B are tab-shaped, howeverother shapes may also be used.

The vertebra control ring in FIG. 18A is shown with three holes 510through the edge of the vertebra that may act, e.g., as attachment sitesfor the tendon cable 312 if the vertebra is the most distal vertebra ina segment, or as a throughway for a tendon cable that can actuate thesegment in which the vertebra is used. These holes 510 can also be usedto attach the sleeve of the Bowden-type tendon cable 314 when thevertebra is the most proximal control disk in a segment. Alternatively,rather than a hole 510, the attachment sites could be a recess or otherspecialized shape. Although FIG. 18A shows three holes 510, the numberof holes may depend upon the number of tendons used to control thesegment to which the vertebra belongs. Since the holes 510 may be usedas attachment sites for the tendons, there are as many holes as thereare tendons controlling the segment.

The outer edge of the vertebra in FIG. 18A may be scalloped to providespaces 512 for tendon housings of tendons that control more distalsegments and bypass the vertebra. These tendon bypass spaces preferablyconform to the outer diameter of the tendons used. The number of tendonbypass spaces 512 may vary depending on the number of tendons. Also, theorientation of the tendon bypass spaces may be varied if it is desirableto vary the way in which the bypassing tendons are wound around theendoscope. For example, the spaces 512′ in FIG. 18C are oriented at anangle relative to the longitudinal axis of the vertebra, allowing thetendons to wind around the body of the endoscope as they projectproximally. Furthermore, the tendon bypass spaces could be lubricated orcomposed of a lubricious material in order to facilitate free movementof the bypassing tendons across the segment, and prevent interferencebetween the bending of the segment and the bypassing tendons.

FIGS. 18B and 18C show side views of the same vertebra as FIG. 18A. Thetwo pairs of hinge joints 508, 506 are shown. Hinge joints 508, 506 arepreferably located 90° apart and extend axially so that the hinge jointscan pivotally mate with hinge joints from adjacent vertebrae. Thismating 520 with adjacent vertebrae is more clearly seen in FIG. 18C.These hinges can be joined, pinned, or connected through the holes 525as shown 522. Alternatively, hinges may also be made from materialsutilizing, e.g., thermoplastics, shape memory alloys, etc. Once hinged,each vertebra can rotate relative to an adjoining vertebra in one axis.However, because vertebrae are hinged to each other in directionsalternating by 90°, an assembly of multiple vertebrae is able to move invirtually any direction. The greater the number of vertebrae joined inthis manner, the greater the range of motion. In one embodiment, two toten vertebrae are used to comprise one segment, achieving a length ofaround 4 cm to 10 cm per segment. The dimensions of both the vertebraeand the hinge joints can be varied, e.g., longer hinge joints will havea greater bending radius when joined to another vertebra. Furthermore,the number of vertebrae per segment can vary, e.g. more than tenvertebrae could be used.

FIGS. 18D and 18E show another variation of a vertebra in sectional andperspective views, respectively. In FIGS. 18D and 18E, the tendons thatbypass the segment may be contained within the body of the vertebra in atendon bypassing space 550 rather than along the outer edge of thevertebra as shown in FIG. 18A. The vertebra of FIGS. 18D and 18E showfour tendon bypassing spaces 550, and each space can hold approximatelyfifteen bypassing tendon sleeves. The number, shape and sizes of thetendon bypassing spaces can be varied. For example, a vertebra couldhave two tendon bypassing spaces that could hold more than thirty-fivetendon sleeves. Moreover, the tendon bypassing space could also belocated on the inside of the central aperture or lumen of the vertebra504.

Although FIG. 18D shows tendon sleeves holding only a single tendoncable 560, more than one tendon cable could be contained in a tendonhorsing or sleeve. For example, if three tendons articulate a segment,all three tendons could be contained in a single tendon housing. Such acombined tendon housing could further utilize lubrication to accommodateindependent movement by individual tendon cables and/or could be dividedinto compartments that isolate the tendons within the housing.

FIG. 18E also shows a perspective view of the binge joints 506, 508 thatcan pivotally mate with pairs of hinge joints from adjacent vertebrae.Although FIGS. 18A and 18B shows two pairs of hinge joints projectingaxially, a single hinge joint on each face of the vertebra could also beused. Moreover, as long as the hinge joints can pivotally mate withadjacent vertebrae, the hinge joints can be located at different radiallocations from the center of the vertebra. For example, the pairs ofhinge joints shown in FIGS. 18A to 18C are located closer to the centerof the vertebra than the hinge joints in FIGS. 18D and 18E.

FIG. 19A and 19B illustrate a second variation of control ring. Thevariation shown in the figure utilizes a flexible backbone 601preferably made of a material that is relatively non-compressible andnon-extensible, to which control rings 602 are attached at intervals.This structure allows bending in a continuous curve in any desireddirection. FIG. 19A shows a side view of one controllable segment ofthis variation with the outer layers removed to show the control ringsand backbone. Multiple control rings 602 may be attached to the flexiblebackbone at regular intervals. Fewer or more control rings could be usedto comprise a single segment depending upon the desired degree ofarticulation. The tendon cable 312 attaches to the most distal controlring of the segment 604. As with the vertebra-type variation, thiscentral backbone embodiment is shown actuated by three tendons 310attached at sites equally spaced around the edge of the most distalcontrol ring of the segment 604. The tendon cables controlling thesegment 312 pass through spaces or holes 610 defined in the controlrings 602 through which they are free to move. These holes 610 could belubricated, lined with a lubricious material or the control rings 602may be composed of some lubricious material to facilitate cable motionthrough the holes 610. The tendon sleeve preferably attaches at alocation 614 to the most proximal control ring in the segment 612. Whena tendon 312 is placed under tension, this force is distributed alongthe entire segment Because the inner tendon cable 312 is freely slidablewithin the tendon sleeve 314, and the tendon sleeve is fixed at bothends of the tendon 614, pulling on the tendon cable causes bending onlyin the selected segment.

FIG. 19A also shows the first control ring of a more proximal segment604′. The tendons controlling the more distal segment may pass over theoutside of the more proximal segments as they project proximally to theactuators. The outer edge of the control rings for the flexible backboneembodiment are shown with channels or tendon bypassing spaces 616 forbypassing tendons, as seen in FIG. 19B. As with the vertebra-typecontrol rings, these tendon bypassing spaces could also be locatedwithin the control ring, for example, in an enclosed tendon bypassingspace.

FIG. 19B shows an end view of control ring 602 which may be used withthe flexible backbone embodiment of the endoscope. The center of thecontrol ring contains a channel through which the flexible backbone 601can be attached. A number of additional channels through the controlring 618 are also shown. These channels can be aligned with channels inneighboring control rings to form an internal lumen or channel for afiber optic imaging bundle, illumination fibers, etc. as discussedabove. Moreover, adjacent control rings may be spaced adjacently to oneanother at uniform or various distances depending upon the desireddegree of bending or control. FIG. 19B shows three equally spaced holes610 through which the tendon cable can pass; these holes 610 could alsobe used as attachment sites for the tendon cable, e.g., when the controlring is the most distal control ring in the segment 604, or for thetendon cable sleeve, e.g. when the control ring is the most proximalcontrol ring in the segment 612. These holes 610 could be shapedspecifically to receive either the tendon end or the tendon sleeve.Control rings of other designs could be used for different regions ofthe segment, or for different segments.

FIGS. 20A to 20C illustrate a variation of the tendon driven endoscopenavigating a tortuous path. The path 701 is shown in FIG. 20A. Thispathway may represent a portion of colon, for example. In FIG. 20A, thedistal tip of the device 704 approaches the designated bend. FIG. 20Bshows the distal tip being steered 705 to assume the appropriate curve.This steering could be performed manually by the user, e.g. a doctor, orautomatically using an automatic detection method that could determinethe proximity of the walls of the pathway. As described, the bending ofthe steerable tip is performed by placing tension on the tendon, orcombination of tendons that results in the appropriate bending.

The device is then advanced again in FIG. 20C; as it is advanced, theselected curve is propagated down the proximal length of the endoscope,so that the bend of the endoscope remains in relatively the sameposition with respect to the pathway 701. This prevents excessivecontact with the walls, and allows the endoscope to move more easilyalong the tortuous pathway 701. The endoscope is in continuouscommunication with the motion controller, and the motion controller canmonitor the location of the endoscope within the pathway, e.g., depth ofinsertion, as well as the selected bends or curves that define thepathway of the endoscope. Depth can be determined by, e.g., the axialmotion transducer 49 previously described, or by more direct measurementtechniques. Likewise, the shape of each segment could be determined bythe tension applied to the tendons, or by direct measurement, such asdirect measurement of displacement of the tendon cables. The motioncontroller can propagate the selected shape of a segment at a specifiedlocation, or depth, within the body, e.g., by setting the lengths of thesides of more proximal segments equal to the corresponding lengths ofthe sides of more distal segments as the device is moved distally. Thecontroller can also use this information to automatically steer the bodyof the endoscope, or for other purposes, e.g. creating a virtual map ofthe endoscope pathway for analytic use.

In addition to measuring tendon displacement, the motion controller canalso adjust for tendon stretch or compression. For example, the motioncontroller can control the “slack” in the tendons, particularly intendons that are not actively under tension or compression. Allowingslack in inactive tendons reduces the amount of force that is requiredto articulate more proximal segments. In one variation, the umbilicus atthe distal end of the endoscope may contain space to allow slack inindividual tendons.

The bending and advancing process can be done in a stepwise orcontinuous manner. If stepwise, e.g., as the tendon is advanced by asegment length, the next proximal segment 706 is bent to the same shapeas the previous segment or distal steerable portion. A more continuousprocess could also result by bending the segment incrementally as thetendon is advanced. This could be accomplished by the computer control,for example when the segments are smaller than the navigated curve.

Controllable segments, including the steerable distal portion, can beselected to have different dimensions, e.g., different diameters orlengths, even within the same endoscope. Segments of differentdimensions may be desirable because of considerations of space,flexibility and method of bending. For example, the more segments in anendoscope, the further it can be steered within a body cavity; however,more segments require more tendons to control the segments. FIGS. 21 and22 illustrate two variations on tendon driven endoscopes.

FIG. 21 shows a tendon driven endoscope variation that has segments 800of differing diameters. More distal segments may have a smaller diameter803 than more proximal segments, e.g., 802, 801. The diameter of atypical endoscope could decrease from, e.g., 20 mm, down to, e.g., 12.5mm. The endoscope shown in FIG. 21 appears telescoped, as the diameterdecreases distally in a stepwise manner. This design would beresponsive, e.g., to internal body structures that become increasinglynarrow. This design would also help accommodate bypassing tendons frommore distal segments as they proceed towards the proximal actuatorsbecause of the larger diameter of the more proximal segments. FIG. 21shows four differently sized segments; however, virtually any number ofdifferently sized segments could be used. Moreover, although thesegments appear stepped in this variation, the outer surface may begently tapered to present a smooth outer surface decreasing in diametertowards the distal end.

FIG. 22 shows another variation of the tendon driven endoscope that hassegments of different lengths. Using segments of different lengths mayrequire fewer overall segments 900 to construct an equivalent length ofarticulatable endoscope. As shown in FIG. 22, more proximal segments 901are increasingly longer than more distal, e.g., 902, 903, segments. Forexample, segment length could be decreased from 20 cm at a proximalsegment down to 6 cm at a distal most segment The lengths may bedecreased incrementally segment to segment by a constant factor;alternatively, lengths may be decreased geometrically, exponentially, orarbitrarily depending upon the desired articulation. In practice thisresults in an “averaging” of curves by more distal segments as bends andturns are propagated proximally. In order to accomplish this, the motioncontroller may be configured to accommodate the differently sizedsegments accordingly. Alternatively, endoscopes could be comprised of acombination of segments of different length and thickness, dependingupon the application.

The tendons that articulate the segments are in mechanical communicationwith the actuators. However, it may be desirable to have the insertabledistal portion of the endoscope be removable from the actuators andcontroller, e.g., for cleaning or disinfecting. A quick-releasemechanism between the proximal end of the endoscope and the actuators isan efficient way to achieve an endoscope that is easily removable,replaceable or interchangeable. For example, the proximal ends of thetendons can be organized to allow predictable attachment tocorresponding actuators. The tendons may be organized into a bundle,array, or rack. This organization could also provide other advantages tothe endoscope, such as allowing active or passive control of the tendonslack. Furthermore, the proximal ends of each tendon can be modified toallow attachment and manipulation, e.g., the ends of the tendons may beheld in a specially configured sheath or casing.

While the present invention has been described herein with respect tothe exemplary embodiments and the best mode for practicing theinvention, it will be apparent to one of ordinary skill in the art thatmany modifications, improvements and subcombinations of the variousembodiments, adaptations and variations can be made to the inventionwithout departing from the spirit and scope thereof.

What is claimed is:
 1. An endoscopic device for approximating tissuewithin a hollow body organ, comprising: an elongated body having aplurality of articulatable segments and a steerable distal portion,wherein each of the segments are configurable to assume a selected shapealong an arbitrary path when the elongated body is advanced distally orproximally; a first tissue approximation component positioned about theelongated body, wherein the first component is adapted to radiallyexpand and adhere a first region of tissue to a plurality of tissuegripping regions circumferentially located about the first component;and a second tissue approximation component positioned about theelongated body proximally of the first component, wherein the secondcomponent is adapted to radially expand and adhere a second region oftissue to a plurality of tissue gripping regions circumferentiallylocated about the second component, wherein the first component and thesecond component are adapted to approximate and securely fasten thefirst region to the second region of tissue.
 2. The endoscopic device ofclaim 1 wherein the first and the second tissue approximation componentseach comprise a radially expandable ring.
 3. The endoscopic device ofclaim 1 wherein the first and the second tissue approximation componentseach comprise a radially expandable balloon.
 4. The endoscopic device ofclaim 1 wherein the plurality of tissue gripping regions on each of thefirst and the second tissue approximation components comprise vacuumports.
 5. The endoscopic device of claim 1 wherein the plurality oftissue gripping regions on each of the first and the second tissueapproximation components comprise retractable fasteners.
 6. Theendoscopic device of claim 5 wherein the retractable fasteners areselected from the group consisting of needles, hooks, and barbs.
 7. Theendoscopic device of claim 1 wherein the first tissue approximationcomponent is adapted to slide longitudinally towards the second tissueapproximation component along at least a portion of the elongated bodywithin rails or grooves defined along the elongated body such that thefirst region is adjacent to the second region of tissue.
 8. Theendoscopic device of claim 1 wherein the second tissue approximationcomponent is adapted to slide longitudinally towards the first tissueapproximation component along at least a portion of the elongated bodywithin rails or grooves defined along the elongated body such that thefirst region is adjacent to the second region of tissue.
 9. Theendoscopic device of claim 1 wherein the first and the second tissueapproximation components are each adapted to slide longitudinallytowards one another along at least a portion of the elongated bodywithin rails or grooves defined along the elongated body such that thefirst region is adjacent to the second region of tissue.
 10. Theendoscopic device of claim 1 wherein the first or the second tissueapproximation component contains a plurality of fasteners adapted tofasten the first region to the second region of tissue.
 11. Theendoscopic device of claim 10 wherein the fasteners are selected fromthe group consisting of staples, clips, screws, adhesives, sutures, andcombinations thereof.
 12. A method of endoscopically approximatingtissue within a hollow body organ, comprising: positioning an elongatedbody adjacent to a portion of tissue to be excised from the hollow bodyorgan; releasably fastening a first region of tissue circumferentiallyabout a first tissue approximation component and a second region oftissue circumferentially about a second tissue approximation componentsuch that the tissue to be excised is positioned between the first andthe second tissue approximation components; removing the tissue to beexcised from between the first and the second tissue approximationcomponents; approximating the first and the second tissue approximationcomponents such that the first and the second regions of tissue areadjacent to one another; and fastening the first region of tissue to thesecond region of tissue.
 13. The method of claim 12 wherein the firstand the second regions of tissue are releasably fastened to the firstand the second tissue approximation components, respectively, via avacuum force.
 14. The method of claim 12 wherein the first and thesecond regions of tissue are releasably fastened to the first and thesecond tissue approximation components, respectively, via a plurality offasteners.
 15. The method of claim 14 wherein the fasteners areretractable.
 16. The method of claim 12 wherein releasably fasteningcomprises radially expanding the first and the second tissueapproximation components into contact with the first and the secondregions of tissue, respectively.
 17. The method of claim 12 whereinremoving the tissue to be excised comprises laparoscopically excisingthe tissue from between the first and the second tissue approximationcomponents.
 18. The method of claim 12 wherein approximating the firstand the second tissue approximation components comprises longitudinallytranslating the first and the second tissue approximation componentstowards one another along the elongated body.
 19. The method of claim 12wherein fastening the first region of tissue to the second region oftissue comprises stapling or suturing the first region to the secondregion via the first or the second tissue approximation component. 20.The method of claim 12 further comprising radially reducing a diameterof the first and the second tissue approximation components.